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Indocyanine Green Imaging for Bariatric Surgery
Phase 4
Recruiting
Led By Allan Okrainec
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial uses a special imaging technique with a dye to help doctors see blood flow during gastric bypass surgery. It aims to reduce complications like ulcers and leaks by ensuring good blood flow at surgical connections. The study focuses on patients having this type of weight-loss surgery.
Who is the study for?
This trial is for adults over 18 who are eligible for Roux-en-Y gastric bypass (RYGB) surgery in Ontario and can commit to the bariatric program's follow-up, including lifestyle changes. They must be able to consent and may have had treatment for a marginal ulcer. It excludes those with allergies to indocyanine green or Sodium Iodide, substance abuse/smoking issues, unwillingness to take PPIs post-op, pregnancy plans within two years, or bleeding/coagulation disorders.
What is being tested?
The study tests if using the Stryker 1688 AIM system along with Indocyanine Green dye helps surgeons see blood flow during RYGB surgery better. The goal is to check if this method reduces complications like ulcers, leaks, and strictures after surgery.
What are the potential side effects?
Potential side effects include allergic reactions to Indocyanine Green such as itching or rash; however specific side effects related directly from its use in this surgical context will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The applicability of ICG as an indicator of anastomotic blood flow during bariatric surgery.
Secondary study objectives
The impact of ICG imaging on the rate of marginal ulcer and other complications (leaks, strictures).
To evaluate the safety of routine use of NIF imaging using ICG in bariatric patients.
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Interventional group (with drug)Experimental Treatment2 Interventions
The interventional group will receive indocyanine green during bariatric surgery inside the operating room before and after making the gastrojejunostomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indocyanine green
2016
Completed Phase 4
~1720
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for obesity include bariatric surgery and pharmacological interventions. Bariatric surgery, such as Roux-en-Y gastric bypass, works by altering the gastrointestinal tract to reduce food intake and nutrient absorption, leading to significant weight loss and improvement in obesity-related conditions.
Pharmacological treatments often target appetite regulation, fat absorption, or metabolic rate. The use of Near-Infrared Fluorescence (NIF) Imaging in bariatric surgery ensures proper blood flow to the surgical site, reducing complications like leaks and strictures, which is crucial for patient recovery and long-term success.
The Feasibility of Examining the Effects of Gastric Bypass Surgery on Intestinal Metabolism: Prospective, Longitudinal Mechanistic Clinical Trial.
The Feasibility of Examining the Effects of Gastric Bypass Surgery on Intestinal Metabolism: Prospective, Longitudinal Mechanistic Clinical Trial.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,519 Previous Clinical Trials
502,821 Total Patients Enrolled
13 Trials studying Obesity
893 Patients Enrolled for Obesity
Stryker EndoscopyIndustry Sponsor
4 Previous Clinical Trials
1,730 Total Patients Enrolled
Allan OkrainecPrincipal InvestigatorUniversity Health Network, Toronto
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